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Author Topic: Deep brain stimulator - Electrodes  (Read 77602 times)
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dennis100
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« Reply #120 on: January 20, 2014, 03:02:42 PM »

Device Problem Malposition of device
Event Date 07/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
>.

 
Event Description
Literature: walker hc, watts rl, guthrie s, wang d, guthrie bl, bilateral effects of unilateral subthalamic deep brain stimulation on parkinson's disease at 1 year. Neurosurg. 2009; 65(2): 302-9. Summary: this article presents a prospective study that investigated the effects of unilateral stn dbs on motor function in 37 pts with moderate to advanced idiopathic parkinson's disease. The objective of the study was to quantify the benefit of unilateral dbs on contralateral, ipsilateral, and axial symptoms of advanced parkinson's disease. The pt's were evaluated "off" medication preoperatively (baseline), and then at 3, 6, and 12 months postoperatively. Reported event: one pt had poor electrode placement which required repeat surgery to reposition the lead. The pt did reach one-year follow-up. Additional info has been requested, but was no. T available as of the date of this report. Reference literature article attached to mfr report# 2182207200905822.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1447222
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dennis100
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« Reply #121 on: January 20, 2014, 10:25:35 PM »

Device Problem Migration of device or device component
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
 
Event Description
Stimulation effects from the left-sided electrode stopped. It was determined that the deep brain stimulation electrode was dislocated (date unk). The patient was hospitalized and the electrode was re-implanted. Afterwards, the patient's medications were adjusted. The investigator judged the event to probably be related to surgery and possibly related to the deep brain stimulation system. The event resolved completely in 2007. As a result of a review of our mdr procedure with fda, it was determined that events in clinical studies should have been reported with in a 30-day time frame. We are filing these late reports as directed by the staff.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1520178
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dennis100
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« Reply #122 on: January 20, 2014, 10:27:33 PM »

Model Number IPGNEURO
Device Problem Intermittent continuity
Event Date 01/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that since the device was replaced several months ago, the patient had been experiencing increased stimulation about 50 times per day. The patient stated it felt like the stimulation was going off and then on. The patient noted he was "a little dizzy". The logs noted no activations and impedances looked good at 486 ohms and current was 82, 1-, 2-, c+. One electrode was out of range, but not being used. The patient had device reprogrammed as contact 1 had previously been negative and was changed to contact 2 negative and increased the amplitude. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516803
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dennis100
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« Reply #123 on: January 20, 2014, 10:29:18 PM »

Model Number IPGNEURO
Device Problem Migration of device or device component
Event Date 02/16/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4). See manufacturer report number: 2182207200907584.

 
Event Description
Literature: o'sullivan d, pell m. Long-term follow-up of dbs of thalamus for tremor and stn for parkinson's disease. Brain res bull. 2009; 78(2-3): 119-121. Summary: dbs of the vim nucleus of the thalamus maintains long-term benefit for tremor due to essential tremor or to severe tremulous parkinson's disease. As far as bilateral stn stimulation, it maintains the benefit for the movement disorder aspect of parkinson's disease, such as tremor, rigidity and bradykinesia, but in the author's experience, does not prevent the progression of the disease and therefore is of no benefit for the non-dopaminegic aspects of the disease. Event: it was reported that the patient developed tolerance and response to stimulation failed over the follow-up period of 5 years. It was considered that the electrode had migrated.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516801
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dennis100
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« Reply #124 on: January 20, 2014, 10:31:10 PM »

Model Number IPGNEURO
Device Problems Disconnection; High impedance
Event Date 09/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the patient's left brain electrode was not providing any real benefit and very little in the way of stimulation induced adverse effects (no dysarthria and less paresthesia than would be expected) even with monopolar at three contacts up to around 7 volts with high pulse widths (210). Her right brain electrode was providing almost complete tremor control at 1. 7 volts. Impedances were high in 0 monopolar and 0+2, 0+3 but everything else appeared fine during operating test stimulation. Current impedace readings were >4000 ohms x-rays revealed that the left lead had disconnected from the extension. The patient was scheduled for a revision in 2009. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516345
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dennis100
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« Reply #125 on: January 22, 2014, 02:35:49 AM »

Device Problem Fracture
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg. 2009;6(supp s):196-201. Summary: this article present a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: three pts underwent electrode replacement due to rupture. Reference mfr report #3007566237201001308.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617912
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dennis100
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« Reply #126 on: January 22, 2014, 02:36:25 AM »

Device Problem Device operational issue
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg. 2009; 6 (supp s): 196-201. Summary: this article presents a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: four pts underwent electrode replacement due to lead malfunction without proven rupture. Reference mfr report #3007566237201001317.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617921
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dennis100
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« Reply #127 on: January 22, 2014, 02:36:53 AM »

Device Problem No Known Device Problem
Event Date 12/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: maldonado il, roujeau t, cif l, et al. Magnetic resonance-based deep brain stimulation technique: a series of 478 consecutive implanted electrodes with no perioperative intracerebral hemorrhage. Neurosurg, 2009;6(supp s):196-201. Summary: this article presents a retrospective study of all deep brain stimulation (dbs) electrode implants at a given institution between 1996 and 2007. The records were retrieved from a computerized database. A total of 478 electrodes were implanted in 220 consecutive procedures were performed in 194 pts. The aim of the study was to determine the safety of dbs technique consisting of a combination of routine general anesthesia, magnetic resonance imaging direct targeting, and a single penetration technique in a large population of pts undergoing implant secondary to movement disorders. No microelectrode recording or intraoperative stimulation was performed. Reportable event: two pts underwent electrode replacement due to infection. Reference mfr report#3007566237-2010-01234.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1617814
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dennis100
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« Reply #128 on: January 22, 2014, 07:30:36 AM »

Model Number 7426
Device Problem No Information
Event Date 05/01/2003
Event Type  Malfunction 
Event Description
It was reported by the hcp, 'there was attempt at revision in (b) (6) 2003 because of problems with the electrodes, but because of difficulty with the hardware, the revision was not done. " no symptoms or outcome were reported. Additional info has been requested; a follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1639314
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dennis100
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« Reply #129 on: January 22, 2014, 07:31:54 AM »

Device Problem Migration of device or device component
Event Date 01/14/2010
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: lee j-y, jeon bs, paek sh, lim yh, kim m-r, kim c. Reprogramming guided by the fused images of mri and ct in subthalamic nucleus stimulation in parkinson's disease. Clin neurol neurosurg. 2010; 112(1): 47-53. Summary: this article presents a study of 65 pts with parkinson's disease who underwent bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) between march 2005 and september 2006 and had been managed for at least 6 months within conventional programming based on physiological responses. The aim of the study was to evaluate the usefulness of a visual info about the location of the contacts in dbs programming, and compare the outcome of stn before and after reprogramming guided by the fused image of mri and ct. Reportable event: some pts appeared to have a significant shift in the location of the electrodes between the immediate and 6-month post-operative ct. The shift moved in the ventral direction. The shift was felt to be partly due to csf leakage during the operation. No pt treatment or outcome was reported. Reference mfr report #3007566237201001755. See literature article attached to mfr report# 3007566237201001696.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1628499
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dennis100
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« Reply #130 on: January 22, 2014, 09:12:42 AM »

Device Problems Premature discharge of battery; Communication or transmission issue; Electrical shorting
Event Date 10/01/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b) (4).

 
Event Description
The pt experienced a loss of therapy efficacy. Approx 3 weeks later, the pt was seen in clinic. No telemetry could be established between the deep brain stimulator and the physician programmer. It was determined that there was a short in one of the electrode combinations. This combination was inadvertently programmed to be used in therapy, causing premature deep brain stimulator battery depletion. The neurostimulator was replaced. Afterward, the pt's therapy resumed to a satisfactory level.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614500
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dennis100
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« Reply #131 on: January 22, 2014, 09:13:16 AM »

Device Problem Migration of device or device component
Event Date 12/31/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: york mk, wilde ea, simpson r, jankovic j. Relationship between neuropsychological outcome and dbs surgical trajectory and electrode location. J neurol sci. 2009; 287(1-2): 159-171. Summary: this article presents a study of an standardized eval of the location of the deep brain stimulation (dbs) electrode tip and the active electrodes, the surgical trajectory through which they were placed, and their relation to neuropsychological change scores in 17 pts implanted with bilateral subthalamic nucleus (stn) dbs using 6 month post-surgical magnetic resonance imaging data. Reportable event: one pt's left electrode migrated outside the radiologically defined stn. The pt did not receive good motor benefit following surgery. The left stimulation was eventually turned off following the mri results. The pt elected not to have a revision of the dbs electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1586065
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dennis100
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« Reply #132 on: January 23, 2014, 07:34:21 AM »

Model Number 7426
Device Problem Malposition of device
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: moro e, hamani c, poon yy, et al. Unilateral pedunculopontine stimulation improves falls in parkinson's disease. Brain. Jan; 133 (pt 1): 215-224. Summary: this was an evaluation of ppn dbs in six patients with intra-operative neurophysiological and postoperative imaging characterization of the surgical target. The aim of this prospective study was to investigate the safety and the effects of unilateral ppn dbs on motor signs, especially falls, freezing of gait and postural stability in patients with advanced parkinson's disease. Event: one patient had the electrode repositioned 4 months after the initial implant due to very low threshold of stimulation-induced paresthesias and the lack of any motor improvement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658303
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dennis100
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« Reply #133 on: January 23, 2014, 07:35:38 AM »

Model Number LEADMVD
Device Problem Positioning Issue
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: xiaowu h, xiufeng j, xiaoping z, et al. Risks of intracranial hemorrhage in patients with parkinson's disease receiving deep brain stimulation and ablation. Parkinsonism relat disord. Feb; 16(2): 96-100. Summary: the study analyzed risk factors (patient age, sex, blood pressure, anatomical targets, number of microelectrode recording penetrations and surgical modality) for hemorrhage in a large series of deep brain stimulation (dbs) and ablation procedures in patients with advanced parkinson's disease (pd). Event: dbs electrodes were placed. In 87 patients who did not undergo microelectrode recording (mer), the target position was confirmed by intraoperative mri scan with a stereotactic frame. The actual target was modified in 21 cases in subsequent procedures; 19 of which were adjusted by 2. 0 - 3. 5 mm in depth.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656252
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« Reply #134 on: January 23, 2014, 08:54:01 AM »

Device Problems Break; Material twisted
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: gelabert-gonzalez m, relova-quinteiro jl, castro-garcia a. "twiddler syndrome" in two patients with deep brain stimulation. Acta neurochir (wien). Mar; 152(3): 489-491. Summary: this article reviews the clinical cases of two patients with parkinson's disease who had subthalmic bilateral electrodes implanted and presented with twiddler syndrome 2 and 3 years after surgery. Event: the patient is a (b) (6) woman with a 12 year history of parkinsons disease, treated with levodopa and amantadine. The patient was admitted in (b) (6) 2005. Quadripolar dbs electrodes were implanted in each stn and a pulse generator was implanted in the abdominal wall 2 days later and sutured to the fascial plane. Following good clinical recovery, the 1 year follow up period showed an important reduction of symptoms. Two years later, the patient presented with a disabling tremor and increased rigidity on the right side of the body. Radiographs of the stimulation system showed the left electrode was fractured at the neck, and the extensions wires were intertwined from the neck to the abdominal bag. The patient reported having twisted the generator box because "it didn't feel right. " surgery was performed to replace the left electrode. Postoperative outcome was uneventful and the patient was discharged 6 days later. It was also noted the patient had no psychiatric disorder, however, they admitted they had often manipulated the generator in the abdominal sack without perceiving any discomfort. See literature article attached to mfr report # 3007566237201002832.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656253
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dennis100
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« Reply #135 on: January 23, 2014, 09:12:06 AM »

Model Number LEAD
Device Problems Difficult to position; Device operational issue
Event Date 03/31/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Literature: fytagoridis a, blomstedt p. Complications and side effects of deep brain stimulation in the posterior subthalamic area. Stereotact funct neurosurg. 2010;88(2):88-93. Summary: forty consecutive patients (67% men) operated with dbs in the posterior subthalamic area (psa) were analyzed for complications and side effects of the procedure. Twenty-seven patients had essential tremor, 8 had parkinson's disease, 2 had dystonic tremor, 1 had cerebellar tremor, 1 had neuropathic tremor and 1 writer's cramp. The mean age at surgery was ((b) (6)). The pts were followed for a mean time of 34 months (range 3-59). All procedures were performed by one surgeon during the period 2004-2008. Fifty-four dbs leads were implanted in these 40 patients, requiring a total of 57 tracks. Twenty-nine patients were operated in the left hemisphere, 7 in the right and 4 bilaterally. Four patients received an extra ipsilateral electrode in the psa due to an ambiguous response during perioperative stimulation of the original electrode. The pts were hospitalized for a mean of 7. 4 days (range 2-15). Reportable events: one procedure was aborted in the operation theatre and completed at a later occasion because the durotomy provoked a generalized seizure. One procedure was aborted in the operation theatre and completed at a later occasion due to suboptimal placement of the electrode in a pt too exhausted to allow a relocation of the electrode in the same session. Revision of the extension cables was performed in 2 patients due to straining and a feeling of tightness. One pt had an irritating granuloma removed from the infraclavicular scar. The implantable pulse generator malfunctioned in 1 patient with 2 ipsilateral electrodes. This problem was related to the stn electrode, and the clinical result was not affected. The source literature indicated the dbs lead models used were either 3387 or 3389, the electrodes were secured with a stimloc bur hole cover, extension models were not indicated, and the ipg model was 7428 (kinetra) in 37 of the 40 patients and model 7426 (soletra) in 3 of the 40 cases. The individuals and models for each event are unk.

 
Manufacturer Narrative
(b) (4). It was not possible to ascertain specific device info from the article. It is also possible several events occurred in one patient. At this time, no additional information was available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676374
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« Reply #136 on: January 23, 2014, 09:46:54 AM »

Model Number 37601
Device Problem Radiofrequency interference (RFI)
Event Type  Malfunction 
Event Description
Medtronic employee reports changes to device programming due to environmental issues. Pt came into the hospital with his device turned off and an additional negative electrode was added. Device was turned back on and reset. Then he had a new lowrad digital format x-ray for another medical condition and device was found to be turned off and rate had changed from 60 to 30. The physician surmises that the wireless capability is what is changing the settings in this instances.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1693661
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« Reply #137 on: January 23, 2014, 09:47:26 AM »

Model Number IPGNEURO
Device Problem Bent
Event Date 01/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The electrode tip was curved. It was explanted. Add'l info has been requested. A f/u report will be submitted if add'l info becomes available.

 
Manufacturer Narrative
(b) (4). The lead was returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676369
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« Reply #138 on: January 23, 2014, 09:48:54 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/01/2010
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: fytagoridis a, blomstedt p. Complications and side effects of deep brain stimulation in the posterior subthalamic area. Stereotact funct neurosurg. 2010;88(2):88-93. Summary: forty consecutive patients (67% men) operated with dbs in the posterior subthalamic area (psa) were analyzed for complications and side effects of the procedure. Twenty-seven patients had essential tremor, 8 had parkinson's disease, 2 had dystonic tremor, 1 had cerebellar tremor, 1 had neuropathic tremor and 1 writer's cramp. The mean age at surgery was (b) (6). The pts were followed for a mean time of 34 months (range 3-59). All procedures were performed by one surgeon during the period 2004-2008. Fifty-four dbs leads were implanted in these 40 patients, requiring a total of 57 tracks. Twenty-nine patients were operated in the left hemisphere, 7 in the right and 4 bilaterally. Four patients received an extra ipsilateral electrode in the psa due to an ambiguous response during perioperative stimulation of the original electrode. The pts were hospitalized for a mean of 7. 4 days (range 2-15). Event: one pt with pd and bilateral implants suffered a postoperative infection. Three days after surgery he developed fever, elevated c-reactive protein, mild intermittent confusion and a discrete left-sided hemiparesis. Signs of inflammation were seen along the right cerebral electrode. The electrode was removed, and samples for bacteriological culture were collected. The cultures were negative and the pt was treated presumptively with antibiotics, and had recovered fully within 1 month. However, after 3 months, the scar over the left electrode became purulent. The second electrode was removed and cultures demonstrated growth of coagulase-negative staphylococcus aureus, enterobacter aerogenes and alpha-hemolytic streptococcus. This pt did not suffer any permanent sequelae.

 
Manufacturer Narrative
 
Event Description
Additional information from another literature article by the author revealed the following additional details regarding this event: literature: blomstedt, p. , bjartmarz, h. Intracerebral infections as a complication of deep brain stimulation. Stereotactic and functional neurosurgery. 2012;90:92-96. The patient, a (b)(6) male with parkinson's disease (pd), had been operated with left-sided vim dbs 7 years before. Due to suboptimal treatment results and disease progression, it was decided to replace the electrode with bilateral electrodes in the zona incerta. The old electrode, which was found to be broken, was removed 2 days before the procedure to facilitate mri. A ct on postoperative day 5 demonstrated an edema around the right electrode, with progression on the following day and a contrast-enhanced area around the edema. Furthermore, similar changes but to a lesser extent were noted around the left electrode. These changes were interpreted as cerebritis with developing abscess. The patient was initially treated with intravenous (vancocin and meronem) and later with oral antibiotics for 8 weeks. Twenty days after the operation, ct demonstrated apparent amelioration of intracerebral changes and recovery of the patient. An mri did however reveal remaining edema on the right side, especially around the tip of the electrode. For this reason, the right electrode was removed. Bacterial culture from the electrode demonstrated growth of (b)(6). Eleven weeks after the initial operation and 3 weeks after discontinuation of antibiotic treatment, the patient presented with headache, vertigo and later rupture of the cranial incision above the entry of the electrode with pus. The patient recovered without any permanent sequelae. This additional information was found in an article also reported in the follow reports, please access these reports for the full article: 3007566237-2012-00962 3007566237-2012-00963 3007566237-2012-00968.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1676370
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« Reply #139 on: January 23, 2014, 10:08:52 AM »

Model Number 3387
Device Problems High impedance; Device operates differently than expected
Event Date 04/01/2010
Event Type  Malfunction 
Event Description
The doctor had a difficult time tunneling during a stage 2 which resulted in stripping the silicone cover off the electrodes. The electrode looked okay, so it was covered with a boot. Impedance measurements for electrode #7 appeared to be greater than 4,000 ohms. The doctor opted to finish the implant since it was still going to be very functional for the pt. Additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1702366
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« Reply #140 on: January 23, 2014, 10:10:10 AM »

Model Number 7424
Device Problem Fracture
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: dilorenzo dj, jankovic j, simpson rk, takei h, powell sz, long-term deep brain stimulation for essential tremor: 12-year clinicopathologic follow-up. Mov disord. 2010;25(2):232-238. Summary: this article describes the clinical course and postmortem pathological finding in a patient with et treated with dbs for 12 years. This (b) (6) woman had a 13 year history of progressive et prior to implantation of bilateral dbs electrodes in the region of her vim thalamic nuclei in 1996, producing immediate relief of arm tremor. Histopathological examination of the brain, performed 12 years after the initial implantation, demonstrated electrode catheter tracts rimmed by 20-25 micron sheath, with multinucleated giant cells and reactive gliosis. Lymphocytic infiltration was seen by l26 immunoreactivity with cd3 (t cells) staining predominating over cd20 (b cells). Cerebellar axonal spheroids and purkinje cell loss were found. The minimal foreign body reaction and gliosis around the electrodes 12 years after implantation supports the long-term safety of dbs. Reportable event: the left vim intracranial electrode fractured at 15 months after initial implantation and was replaced 2 months later. The fracture occurred in the intracranial portion of the lead, 2. 8 cm from the proximal end and involved all four conductor wires. The patient otherwise experienced excellent control of her et bilaterally except during this period of temporary hardware failure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1692635
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« Reply #141 on: January 23, 2014, 10:11:32 AM »

Model Number 7424
Device Problem High impedance
Event Date 01/01/2008
Event Type  Death   Patient Outcome  Death,Hospitalization
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: dilorenzo dj, jankovic j, simpson rk, takei h, powell sz, long-term deep brain stimulation for essential tremor: 12-year clinicopathologic f/u. Mov disord. 2010;25(2):232-238. Summary: this article describes the clinical course and postmortem pathological finding in a pt with et treated with dbs for 12 years. This (b) (6) woman had a 13 year history of progressive et prior to implantation of bilateral dbs electrodes in the region of her vim thalamic nuclei in 1996, producing immediate relief of arm tremor. Histopathological examination of the brain, performed 12 years after the initial implantation, demonstrated electrode catheter tracts rimmed by 20-25 micron sheath, with multinucleated giant cells and reactive gliosis. Lymphocytic infiltration was seen by l26 immunoreactivity with cd3 (t cells) staining predominating over cd20 (b cells). Cerebellar axonal spheroids and purkinje cell loss were found. The minimal foreign body reaction and gliosis around the electrodes 12 years after implantation supports the long-term safety of dbs. Event: the pt's most recent stimulation parameter adjustment was on (b) (6) 2008. The right side impedance values were normal. Left side impedance values were >2000, >2000, 1,400, and 1,834 ohms with respect to the case, respectively, for electrodes 0 to 3. From these last measurements, left electrodes 0 and 1 may have been fractured. Although, the pt's tremor amplitude was at least 75% lower with the dbs turned on compared to that with the dbs off, she developed postural instability which confined her to a wheelchair. In (b) (6) 2008, she was admitted for physical therapy for muscle disuse atrophy, but was discharged after 6 weeks with minimal improvement. She died in her sleep on (b) (6) 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1692688
« Last Edit: February 03, 2014, 02:37:22 AM by dennis100 » Logged
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« Reply #142 on: January 25, 2014, 03:28:51 PM »

Model Number 7426
Device Problems Premature discharge of battery; Fracture; High impedance
Event Date 06/17/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
See manufacturer # 9614453201006593. On (b)(6)2010, the voltages were increased up to 2. 0v without any problems. A problem occurred on (b)(6)2010, upon interrogation. The right side was increased until 2. 2v with no clinical problems. The physician programmer showed a battery usage of 72%. The left side was then increased up to 2. 2v with no problems. The right side was then checked again for usage, and the pt suddenly reacted heavily with acute crying and made it clear he had suddenly experienced severe pain in the abdominal region. The parameters were left unchanged. There were increased impedances on the right side. An x-ray revealed either a fracture or disconnection in the insulation of the left electrode. The neurostimulators (ins) and extensions were explanted. The right ins was suspected of premature battery depletion and pocket stimulation. Upon explant, the right extension did not look normal. There was a disconnection within the insulation. Postoperatively the pt was started with intensive physiotherapy, which the child had never had before. There was an affect in both arms. It was unk if it was related to the device explant or the physiotherapy. No further pt complications were reported.

 
Manufacturer Narrative
(b)(4): analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1824448
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« Reply #143 on: January 25, 2014, 03:29:18 PM »

Model Number 7428
Device Problem Device operational issue
Event Date 07/01/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that electrode 6 was "out of range" on the pt's device. Add'l info was requested.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1824900
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« Reply #144 on: January 25, 2014, 03:30:20 PM »

Model Number 7428
Device Problem High impedance
Event Date 07/13/2010
Event Type  Injury 
Manufacturer Narrative
(b)(4).

 
Event Description
It was reported that just after implant, high impedances were measured (>4000 ohms) between electrode 0 and electrode 1. The pt needs both electrodes for successful therapy so that no successful stimulation was possible. The physician will wait four to six weeks and if impedances are still > 4000 ohms, replacement will be considered. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1801180
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« Reply #145 on: January 25, 2014, 03:30:52 PM »

Model Number 3387
Device Problems Fracture; Kinked
Event Date 06/07/2010
Event Type  Malfunction 
Manufacturer Narrative
(b)(4). Analysis results were not available at the time of this report. A f/u report will be sent when the analysis is completed.

 
Event Description
The lead appeared flimsy at implant. When the surgeon put the lead cap on, it destroyed the electrode. The end of the lead "where metal pieces are" looked bent. The end portion of the lead broke off and it was trimmed. The lead was implanted. There was no pt injury and pt recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1750610
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« Reply #146 on: January 25, 2014, 03:31:40 PM »

Model Number 7426
Device Problems Kinked; Impedance issue; Positioning Issue
Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
(b)(4): the device has been returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

 
Event Description
It was reported lead was explanted due to infection. It was later reported lead was damaged during re-implant. The electrode was damaged while inserting lead through stim loc burr hole cover. The lead was kinked or crimped after insertion and impedances were abnormal. Physician indicated this resulted from sequence of surgical technique and not a faulty electrode. All impedance readings displayed as short circuits. Physician replaced the 1st lead with a new one. The new lead was connected to the current extension and battery. All of the impedances tested within the normal range. The pt's system will be programmed in the next few weeks. There was no pt injury and pt recovered w/o sequela. Add'l info will be provided when it becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1850865
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« Reply #147 on: January 25, 2014, 03:32:08 PM »

Model Number 37601
Device Problem Break
Event Date 08/23/2010
Event Type  Malfunction 
Event Description
It was reported that the carrier broke in the pt's neck and they had to make another incision. When removing the extension, the electrode was destroyed. Different extensions were used and everything was ok after that. Part of the carrier was saved. The pt was stitched up and surgery was completed. The pt's status was not known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1841861
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« Reply #148 on: January 25, 2014, 03:32:38 PM »

Model Number 7428
Device Problem Failure to conduct
Event Date 07/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient's ins was explanted and replaced due to a current leak on the 6/8 electrodes. The patient had a reoccurrence of the previous (treated) symptoms. The patient's outcome was listed as "ok. " no further details or patient symptoms were provided at the time of this report. A follow-up report will be filed if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1834855
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« Reply #149 on: January 26, 2014, 01:48:05 AM »

Model Number IPGNEURO
Device Problem No Information
Event Date 09/28/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported patient had deep brain stimulation (dbs) system in 2004 and changed to implantable pulse generator (ipg) in (b)(6) 2008. According to patient, "the incision on the left side head occurred purulence about a month ago". When he returned to the hospital for programming, physician identified it as infected. After communicating between patient and company, physician decided to remove the infected electrode. The surgery was planned for (b)(6) 2010. The lead was explanted. At the time of this report, no further details were reported. Add'l info was requested and will be provided when it becomes available.

 
Manufacturer Narrative
(b)(4): analysis results were not available at the time of this report. A f/u report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885205
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